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RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Aldesleukin may stimulate natural killer cells to kill tumor cells. Giving chemotherapy followed by autologous natural killer cells and aldesleukin may kill more tumor cells.
- Determine the ability of the administration of autologous natural killer cells and aldesleukin after a nonmyeloablative lymphodepleting preparative regimen to mediate tumor regression in patients with metastatic melanoma or renal cell cancer.
- Determine the rate of repopulation of the natural killer cells in these patients.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients are stratified according to disease (melanoma vs renal cell cancer).
- Leukapheresis: Patients undergo apheresis to collect peripheral blood lymphocytes that are used for in vitro generation of autologous natural killer (NK) cell lymphocytes.
- Nonmyeloablative preparative regimen: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine phosphate IV over 15-30 minutes on days -5 to -1.
- Autologous NK cell infusion: Patients receive autologous NK cells IV over 20-30 minutes on day 0.
- Aldesleukin: Patients receive aldesleukin IV over 15 minutes every 8 hours beginning on day 0 and continuing for up to 5 days (maximum of 15 doses) during the first course and begin a second course 14 days later.
Patients who achieve partial or complete response and then develop progressive disease may receive 1 additional course of therapy as above.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
aldesleukin, therapeutic autologous lymphocytes, cyclophosphamide, fludarabine phosphate
NCI - Surgery Branch
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:43:27-0400
RATIONALE: Treating lymphocytes in the laboratory may help the lymphocytes kill more tumor cells when they are put back in the body. Aldesleukin may stimulate the lymphocytes to kill tumor...
RATIONALE: Aldesleukin may stimulate lymphocytes to kill melanoma cells. Treating lymphocytes with interleukin-21 in the laboratory may help the lymphocytes kill more tumor cells when they...
RATIONALE: An infusion of a patient's lymphocytes that have been treated in the laboratory to remove certain immune cells may be an effective treatment for melanoma. Drugs, such as cycloph...
Chemotherapy Consisting of Fludarabine and Cyclophosphamide Followed By White Blood Cell Infusion, Vaccine Therapy, and Aldesleukin in Treating Patients With Recurrent or Refractory Metastatic Melanoma
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Treated white blood c...
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bi...
Comparative effectiveness of busulfan/cyclophosphamide versus busulfan/fludarabine myeloablative conditioning for allogeneic hematopoietic cell transplantation in acute myeloid leukemia and myelodysplastic syndrome.
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Lymphocytes that show specificity for autologous tumor cells. Ex vivo isolation and culturing of TIL with interleukin-2, followed by reinfusion into the patient, is one form of adoptive immunotherapy of cancer.
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
Mucoproteins isolated from the kidney bean (Phaseolus vulgaris); some of them are mitogenic to lymphocytes, others agglutinate all or certain types of erythrocytes or lymphocytes. They are used mainly in the study of immune mechanisms and in cell culture.
A family of sodium-phosphate cotransporter proteins with eight transmembrane domains. They are present primarily in the KIDNEY and SMALL INTESTINE and are responsible for renal and small intestinal epithelial transport of phosphate.
A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....